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Medical Affairs has originally emerged as a reaction because of increasing pressure from regulators to separate medical and commercial functions. Companies have been experiencing increasing internal demand to focus on generation and development of new products rather than managing products after FDA approval.

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Clinical trials generate an extensive amount of statistical data. With the increasing complexity of segregated data collection, it is imperative to have an effective system to manage and to statistically analyse the data to produce end result. Clinical data management system (CDMS) is used for this purpose.

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